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PROTONIX®(pantoprazole sodium)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
PROTONIX® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for:
1.1 Short-Term Treatment of Erosive...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing Schedule
PROTONIX is supplied as delayed-release granules in packets for preparation of oral suspensions or as...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Delayed-Release Tablets:
- 40 mg pantoprazole, yellow oval biconvex tablets imprinted with PROTONIX (brown ink) on one side
- 20 mg pantoprazole, yellow oval biconvex tablets...
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Contraindications
4 CONTRAINDICATIONS
- PROTONIX is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock,...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Presence of Gastric Malignancy
In adults, symptomatic response to therapy with PROTONIX does not preclude the presence of gastric...
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Adverse Reactions
6 ADVERSE REACTIONS
The following serious adverse reactions are described below and elsewhere in labeling:
- Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5....
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Drug Interactions
7 DRUG INTERACTIONS
Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with PROTONIX and instructions for preventing or managing them.
...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from...
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Overdosage
10 OVERDOSAGE
Experience in patients taking very high doses of PROTONIX (greater than 240 mg) is limited. Spontaneous post-marketing reports of overdose are generally within the known safety profile of PROTONIX.
...
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Description
11 DESCRIPTION
The active ingredient in PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets, a PPI, is a substituted benzimidazole, sodium 5-(...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 24-month carcinogenicity study, Sprague-Dawley rats were treated orally with...
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Clinical Studies
14 CLINICAL STUDIES
PROTONIX Delayed-Release Tablets were used in the following clinical trials.
14.1 Erosive Esophagitis (EE) Associated with Gastroesophageal Reflux...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
PROTONIX (pantoprazole sodium) Delayed-Release Tablets are supplied as yellow, oval...
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Medication Guide
| MEDICATION GUIDE PROTONIX (pro-TAH-nix) (pantoprazole sodium)... |
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Instructions For Use
Instructions for Use
Instructions for Use
PROTONIX (pro-TAH-nix)
(pantoprazole sodium)
for delayed-release oral suspension
PROTONIX for delayed-release oral suspension (PROTONIX for oral suspension):...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.